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Breas Medical, Inc. Recall 89776

Description: Breas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384

Breas Medical, Inc. Recall 89776 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0943-2022
Event ID89776
Event DescriptionBreas Ventilator Trolley with the Vivo 50/60/65 and Vivo 45LS ventilator models Article no 007384
Product TypeDevices
DistributionUS Nationwide
Quantity707 units
Recall ReasonVentilator mounting brackets for the Vivo 50/60/65 and Vivo 45LS ventilator models can become detached from the Breas Ventilator Trolley, this may cause the ventilator to fall from the trolley and cause injury to a person who is in the immediate proximity
Device Classification20220420
Device Code InfoTrolleys delivered between June 11th, 2020, and December 3rd, 2021. UDI: 07321820073849
Center Classification Date20220414
Recall Initiation Date20220321
Recalling FirmBreas Medical, Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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